CareFusion expands Alaris warning

The U.K.’s Medicines & Healthcare Products Regulatory Agency issued a 2nd warning for CareFusion‘s Alaris drug pump after the company discovered that the Alaris pumps with broken springs in the plunger assembly could accidentally release a single dose of medication. The U.K. watchdog 1st warned customers in December last year that the pump could release a dose

Turns out unneeded ICD shocks have costs

A Stanford University School of Medicine–led team of researchers has discovered that implantable cardioverter defibrillators that administer shocks unnecessarily could actually do more harm than good. Those who have had a ventricular arrhythmia, heart attack, survived sudden cardiac arrest and have a congenital heart disease typically have an ICD implanted, according to the American Heart

Health insurance industry committee says yes to UDIs in claims forms

The X12 advisory committee—which helps formulate standards for the insurance industry— has recommended changes that will allow standard health insurance claims forms to record unique device identifiers (UDIs). Putting UDIs in claims forms has widespread support. Hospitals, providers, payers, and patient advocacy groups welcome the recommendation, says Ben Moscovitch, who manages health information technology at The

Surmodics raises guidance, beats Q1 earnings

Shares in Surmodics (NSDQ:SRDX) rose today after the medical device maker met expectations on Wall Street with its fiscal 2017 1st quarter results. The Eden Prairie, Minn.-based company posted profits of $2.3 million, or 17¢ per share, on sales of $17.8 million for the 3 months ended Dec. 31, for bottom-line loss of -13.3% on

Trelleborg features engineered coating fabrics, contract manufacturing services for combo products

Trelleborg plans to be on site at MD&M West 2017, a medical technology conference in California next month, highlighting its portfolio of engineered coated fabrics for medical, orthopedic and surgical applications, as well as the company’s contract manufacturing services for drug-device combination products. Trelleborg Engineered Coated Fabrics develops polyurethane, rubber and silicone-coated fabrics for devices such

Raumedic showing off tiny tubing, multilayer tubing at MD&M West

As a polymer component system provider for the medical technology and pharmaceutical industry, Raumedic will be exhibiting at the MD&M West show in Anaheim, Califoria in February. The company will be demonstrating its ability to implement customer ideas in products that expertly combine functionality and cost-effectiveness. This year, the themes guiding Raumedic’s presence at MDM

Physio-Control has a battery problem with its LifePak 1000 AED

Physio-Control said last week that it is launching a voluntary field action for its LifePak 1000 defibrillator, after reports that the device can shut down unexpectedly during treatment. The Redmond, Washington–based company has received 34 reports describing instances when customers have attempted to use the LifePak device and it has shut down due to an

Oventus announces U.S. launch of O2Vent T device for sleep apnea

Oventus, a Brisbane-based medical device company seeking to change the way sleep disorders are treated, announced the U.S. launch of O2Vent T, the first and only FDA-cleared sleep disorder device that provides relief for snoring and obstructive sleep apnea (OSA) via a unique, separate airway that avoids multiple sites of obstruction, including the nose, the soft palate

Another warning for CareFusion’s Alaris drug pump

The U.K.’s Medicines & Healthcare Products Regulatory Agency issued a warning today for Carefusion‘s Alaris syringe drug pumps. The U.K. watchdog said that Alaris pumps with broken springs in the plunger assembly could accidentally release a single dose of medication if the pump also uses non-recommended syringes. “This problem comes about through a combination of using

Researchers’ bionic pancreas outperforms standard insulin pump therapy

Researchers from Boston University have developed a bionic pancreas system that outperformed conventional insulin pump therapy for patients with type 1 diabetes, according to a trial conducted at Massachusetts General Hospital. The team’s work was published in The Lancet.  This device is the latest development in the race to make an entirely closed loop insulin pump system,

Artificial leaf produces drugs using solar energy

Researchers from the Eindhoven University of Technology have reportedly developed a leaf-inspired mini-factory to produce drugs using solar energy. The team’s work could allow medicine to be made in resource-deprived areas, as long as there is sunlight. “Theoretically, you could use this device to make drug compounds with solar energy anywhere you want,” lead researcher

Changing your medical device: 6 things you need to know

Medical device regulatory consultant Michael Drues has never liked the phrase “change management.” The words seem boring to him. “Not only does it not have to be boring, it is incredibly important—and can be exciting and dare I say fun,” says Drues, who is president of Vascular Sciences (Grafton, MA). Whether it involves a medical

Medical device coatings market to double to more than $15 billion

The medical device coatings market’s worth is projected to more than double by 2025, according to a report by Grand View Research. The market is expected to grow at an annual rate of about 7%—from its 2015 value of $7.51 billion to an expected $15.69 billion in the next nine years. Medical device coatings enhance

H&T Presspart and Cohero Health launch first market-ready, fully-connected metered dose inhaler to optimize care of asthma and COPD

H&T Presspart and Cohero Health have launched the first market-ready, intuitive, fully-embedded and connected metered dose inhaler (eMDI) aimed at improving adherence andenabling continually optimized care of patients with asthma and COPD. It is the only eMDI integrated seamlessly with BreatheSmart from Cohero Health, a comprehensive respiratory disease management platform that uniquely enables tracking of

Is a single contract manufacturer the best option?

Eric Sugalski/President/Smithwise For medical device startups, entering the manufacturing stage can be a daunting, frustrating and time-consuming process. Often, medical device startups will meet no-quotes or show stopping quotes from contract manufacturing organizations (CMOs) for their pilot builds. This is often due to the economic realities facing CMOs. It takes a significant amount of up-front